MONITORING

On-site Monitoring

Routine on-site monitoring consists of the check of all items stipulated in  ICH (step 5) / CPMP Guidelines for GCP

These monitoring duties may be grouped into

• record of the actual patient status
• CRF check and source data verification
  incl. control of adherence to protocol and amendments
• update of the adverse events status
• delivery of new or return of unused supplies incl. drug accountability

In-house Monitoring

• telephone monitoring
    as reported interim contact between on-site visits
    as general controlling tool in certain study designs
  
• complete case review by physicians

Monitors

General Education

Monitors are employed or long-term and exclusively contracted freelancers. They regularly attend in-house education courses and are informed by the latest literature. ECRON performs annual ICH GCP exams for their CRAs and SCRAs to ensure highest working standard. Several senior monitors and CRA supervisors are furthermore certified by ACRPI. All monitors in Central & Eastern Europe are physicians with a board certificate of a higher specialisation.

Study Training

Monitors, project manager, data manager and technical staff are trained for each study in advance with regards to study's medical background, it's goals and traps, handling and organization, to make the whole team familiar with the study and to find out necessary organizational adjustments.

Site-specific Solutions

Project manager or CRA supervisors perform site by site visits with monitors, during the initiation phase as well as throughout the study. They discuss site-specific findings and conditions and lay down what and how to follow up consistently.

Motivation

Well-trained monitors, in particular those working only in a small number of projects, feel competent and responsible for “their” investigators.

Furthermore, monitors are given a share of the company's profit according to their performance so that they directly experience a relation between efforts and personal benefit.